Urinary incontinence is a problem faced by both women and men. The most common form of incontinence is known as stress incontinence, and incidences of this form of incontinence are significantly higher in women than in men. Many different forms of treatment are currently in use.
Although most incontinent people are not treated with indwelling catheters, some (for example, certain comatose patients) may not have alternatives other than using indwelling urinary catheters. Urinary catheters that are not indwelling or self-retaining, but can be intermittently inserted into the urinary tract for periodic (or intermittent) drainage, have also been used for fully draining the bladder. Such catheters usually are simple smooth tubes with rounded tips for ease of insertion and therefore are not self-retaining. A drain eyelet is present near the tip of the catheter to allow urine to enter the catheter. Such simple devices may be self-administered by the patient. Many incontinence problems can be helped by the use of such intermittently administered devices. However, for many incontinent female patients, unlike males who can wear external urinary catheters, during the period between drainage using intermittently administered catheters, diaper products must be used. Such diaper products are bulky, inconvenient, and may result in embarrassing situations for the patient if not attended to properly.
Another type of intermittently administered devices include urethral plugs. These plugs, including Foley catheters that are clamped off, are designed to be placed in the urethra and/or the bladder neck, and once in position, in the urethra or bladder neck, are expanded by inflation with gas (air), liquid, or the like. This inflation is typically performed by connecting a syringe, filled with air or liquid, with a valved tube built within the plug body. Before removal, the expanded portion of the plug, must be deflated. Both the inflation and deflation processes require the user to be capable of properly expanding and deflating the device, in order to properly insert it and remove it, and so as not to damage the urethra. These devices require manual deflation prior to removal from the urinary tract, such that an incapacitated (e.g., unconscious) user would risk overfilling of the bladder, causing severe kidney damage and even death.
These conventional plugs are relatively costly to manufacture, and disposable plugs, used once between voidance, are preferred in order to maintain sterility to avoid infection. Accordingly, manufacturing costs are a significant factor in commercial viability of disposable plug devices.
Traditionally, catheter manufacturing methods, such as those for making Foley catheters include processes that involve slipping a band of cured rubber over a double lumen latex rubber tubing and affixing the band on the double lumen tubing by dipping the band and the tubing in a suspension of latex to form an outer layer. The cost of manufacturing traditional Foley catheters has been influenced by the need to use a significant amount of hand labor to make the devices.
It will be appreciated that using such traditional methods to make catheters and other polymeric structures that have a variety of outer shapes and sizes with cavities (especially fluid-filled cavities) between the tubing and the outer layer adds significantly to the cost of production. Moreover, in many cases where a polymeric structure such as a catheter is to have a cavity filled with fluid, traditional manufacturing methods can not be used.
In addition to catheters, numerous devices such as gastronomy devices for transporting fluids into and out of various segments of the gastrointestinal system, for example, the stomach, also have a structure of an overcoat layer on an inner tubular structure defining a cavity therebetween. Many devices also require a self retention capability such as in the case of external feeding tubes.
Providing an automated method of manufacturing these polymeric structures and others would reduce the cost of many products incorporating such polymeric structures so that they would be more competitive in the market place and could be used for disposable products where low cost is essential.
The present invention includes polymeric structures, especially polymeric structures with encapsulated fluid filled cavities. In addition, the present invention provides methods for manufacturing the device of the present invention, that offer substantial advantages over traditional manufacturing methods.